PharmaTher’s 5th FDA orphan drug designation for KETARX™ (ketamine) Phase 2 clinical study results to support proposed Phase 3 development of KETARX™ (ketamine) to treat Rett Syndrome for FDA approval via the 505(b)(2) regulatory pathway TORONTO, Feb. 02, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, today announced that the U.S. Food and Drug Administration (“FDA”) has granted orphan
Today submitted its meeting package with the U.S. Food and Drug Administration to discuss advancing ...
TORONTO, Feb. 01, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in advancing specialty ketamine pharmaceuticals, today submitted its meeting package with the U.S. Food and Drug Administration (“FDA”) to discuss advancing KETARX™ (racemic ketamine) into Phase 3 development as a treatment for levodopa-induced dyskinesia in Parkinson’s disease (“LID-PD”). This Type C meeting allows the Company to discuss with the FDA its plans